Check a claim.

FDA approves a specific product for specific uses. The current Wegovy label lists different forms, groups of people, uses, and limits.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The exact semaglutide products, forms, people, and uses named in current FDA labels.

FDA says compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness, or quality before marketing.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Compounded or otherwise unapproved semaglutide products compared with FDA-approved products.

A study supports only the people, product form, dose, length, approved use, and result that it tested.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The people, product forms, measured results, and study lengths described in the cited product record.

Several insulin products have FDA approval. Long-term studies in people support closely monitored insulin plans for specific groups with diabetes. The exact product and care setting still matter.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

FDA-approved insulin products and closely monitored treatment plans for specific groups with diabetes.

Insulin products can differ in how fast they work and how much medicine they contain. They can also differ in how they enter the body and what their FDA labels allow. Some biosimilars can be substituted under state law. This does not make every insulin product freely exchangeable.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The exact insulin products, amounts of medicine, ways to give them, and labels reviewed.

The DCCT found fewer long-term complications with an intensive plan. It also found about two to three times as many severe low-blood-sugar events. The right treatment level differs by person and needs medical monitoring.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The specific intensive plan and people with type 1 diabetes studied in the DCCT.

Approved product labels and large randomized trials support specific blood-sugar, weight, and cardiovascular outcomes in defined populations.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The labeled and trial populations, outcomes, comparators, and durations for Mounjaro and Zepbound. Mounjaro's heart-risk use was approved August 27, 2026.

Trials estimate effects for studied populations and durations. They do not establish an identical individual response or a universal treatment duration.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The defined populations and follow-up durations in SURMOUNT-1 and SURPASS-2.

FDA does not review compounded drugs for safety, effectiveness, or quality before marketing, so evidence for an approved product cannot simply be transferred.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Compounded or otherwise unapproved tirzepatide compared with approved Mounjaro or Zepbound.

Cell and rat tendon studies report positive healing signals. The scope matters: these results support biological plausibility, not a proven human treatment.

Evidence type

Preclinical evidence
This answer uses research in cells, animals, or other settings outside patient care. It does not show a benefit in people.

Scope

Cell and animal tendon models only; not clinical healing outcomes in people.

Early human work is too small and limited to establish efficacy. Reliable, replicated human outcome evidence is still needed.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Human tendon and muscle-healing claims; existing pilots and a trial registration do not establish benefit.

The 2026 WADA Prohibited List places BPC-157 in S0 non-approved substances, which is prohibited at all times for covered athletes. Whether it is a steroid is irrelevant to that status.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Athletes subject to the current WADA Code and their applicable governing-body rules.

Studies in people found that both hormones stayed higher for a time. This is a change in body measurements, not proof of a health benefit.

Evidence type

Human pharmacology
This answer uses a study of how the substance enters or changes the body in people. This alone does not show a health benefit.

Scope

Short-term changes in GH and IGF-1 measured in the healthy adults studied.

The cited studies did not test lasting changes in body fat, muscle, or what people could do physically.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Lasting changes in body fat, muscle, or what people could do physically. The cited hormone studies did not test these outcomes.

Research papers and sellers may use the name for different forms, including different salts, changed versions, or mixtures with other ingredients.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Products labeled CJC-1295 that differ in form, salt, chemical changes, added ingredients, or quality controls.

A human dose-escalation study measured an episode of GH release. That is a pharmacodynamic effect.

Evidence type

Human pharmacology
This answer uses a study of how the substance enters or changes the body in people. This alone does not show a health benefit.

Scope

Short-term GH pharmacodynamics in the healthy volunteers and route studied.

A biomarker response is not a clinical outcome, and the identified studies did not establish those benefits.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Recovery and body-composition outcomes not established by GH pharmacology or the postoperative-ileus trial.

The randomized trial reported no significant difference from placebo on its key and secondary efficacy analyses.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The postoperative-ileus population, intervention, and efficacy endpoints in the phase 2 trial.

Yes, for defined products, populations, indications, comparators, endpoints, and durations studied in major trials and reviewed labels.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Approved liraglutide products used in the populations and indications studied.

Approved-product evidence includes product quality and labeling that cannot be assumed for every compounded or unapproved item.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Product identity, formulation, quality, and labeling all matter.

LEADER tested a defined cardiovascular composite in a high-risk type 2 diabetes population, not lifespan extension in the general population.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Adults with type 2 diabetes and high cardiovascular risk in LEADER.

The phase 2 trial reported dose-dependent weight reduction over 48 weeks in a defined adult population.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Adults meeting the phase 2 obesity-trial criteria over 48 weeks.

It remains investigational. FDA says retatrutide is not a component of an approved drug and has not been found safe and effective for any condition. Positive trial results and sponsor announcements are not marketing approval.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States regulatory status as reviewed August 1, 2026.

Lilly reported average weight reduction of up to 20.8% in TRIUMPH-2 and up to 22.6% in TRIUMPH-3 at 80 weeks. These are sponsor-reported topline efficacy-estimand figures and group averages, not individual outcomes, and no full peer-reviewed report of either trial was available in the records reviewed here.

Evidence type

Sponsor-reported trial results
This answer uses a trial result reported by the study sponsor. A full report checked by other experts may not be available yet.

Scope

Adults meeting the TRIUMPH-2 (obesity or overweight with type 2 diabetes) and TRIUMPH-3 (severe obesity with established cardiovascular disease) entry criteria at 80 weeks, as disclosed by Lilly in July 2026.

TRIUMPH-3 was not a definitive cardiovascular-outcomes trial. The sponsor reported a hazard ratio of 0.82 (95% CI 0.55 to 1.22) for the five-component major adverse cardiovascular event measure and 1.12 (95% CI 0.64 to 1.96) for the three-component measure. Both intervals include 1.0 and are wide, so studying a molecule in people with cardiovascular disease is not the same as showing it prevents events.

Evidence type

Sponsor-reported trial results
This answer uses a trial result reported by the study sponsor. A full report checked by other experts may not be available yet.

Scope

The TRIUMPH-3 cardiovascular-event analyses as disclosed by Lilly in July 2026, pending a full report.

Lilly states it plans to submit retatrutide for obesity in the first quarter of 2027. A planned submission is a future corporate action, not regulatory acceptance, approval, a prescribing label, or a launch date. Until an approval is recorded by the regulator, the accurate U.S. status remains investigational.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The sponsor-stated first-quarter 2027 U.S. submission plan as reviewed August 1, 2026.

A matching label name does not establish sequence, purity, sterility, formulation, storage, or clinical equivalence. FDA warns that retatrutide products sold directly to consumers as research material are unapproved and of unknown quality.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Products outside an authorized clinical-development supply chain.

A phase 2 study examined cagrilintide alone. A later large study had separate cagrilintide-alone and CagriSema groups. The results apply only to each defined study group.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Adults without diabetes. The 26-week study required BMI 30 or higher, or BMI 27 or higher with high blood pressure or unhealthy blood-fat levels. The 68-week study required BMI 30 or higher, or BMI 27 or higher with a weight-related health problem. All groups received food and activity guidance. Each result applies only to its study group and period. The CagriSema result does not establish the same result for cagrilintide alone.

FDA's current page says cagrilintide is not a component of an approved drug and has not been found safe and effective for any condition. Human research does not equal FDA approval.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States regulatory status as reviewed August 30, 2026.

CagriSema is the investigational combination of cagrilintide and semaglutide. Evidence from the combination is not evidence for cagrilintide alone.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The separate cagrilintide-alone phase 2 and later CagriSema study reviewed here.

FDA's current unapproved-GLP-1 page says cagrilintide cannot be used in compounding under federal law. This is a United States status statement, not a finding that every online product is identical or safe.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States compounding status as reviewed August 30, 2026.

FDA's substance record lists SS-31 and elamipretide as synonyms. It also lists development names such as MTP-131 and Bendavia. A name match does not prove that an online vial has the same quality or product controls.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

FDA substance identity mapping; not a quality or product-equivalence finding.

FDA granted accelerated approval for Forzinity to improve muscle strength in adults and children with Barth syndrome who weigh at least 30 kg. Accelerated approval uses an intermediate measure and requires a confirmatory study.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The Forzinity label and FDA approval records as reviewed August 30, 2026.

FDA says the randomized study did not show superiority to placebo on its initial walking and fatigue measures. The approval used a knee-extensor muscle-strength measure and later extension data.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The randomized Barth syndrome study and its defined measures; this does not establish a result for other diseases or products.

The 24-week MMPOWER-3 trial did not meet its main goals for six-minute walk distance or fatigue compared with placebo.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The 218 adults with genetically confirmed primary mitochondrial myopathy studied in MMPOWER-3 for 24 weeks.

A small healthy-aging study measured a laboratory energy measure. It did not establish better daily energy, less fatigue, longer life, or slower aging.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Healthy older adults in the single study reviewed; a laboratory measure is not the same as a long-term health outcome.

Forzinity is a specific FDA-approved product. An ingredient name or research vial does not establish the same formulation, manufacturing controls, strength, sterility, or clinical evidence.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The named Forzinity product compared with any other material sold under the SS-31 or elamipretide name.

Yes. CASTA and other randomized studies tested the named product in defined groups and settings. The existence of these studies does not prove a benefit for every outcome or product.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The exact Cerebrolysin product, study group, comparison, outcome, and follow-up period in each randomized trial.

CASTA enrolled 1,070 adults, but its main combined recovery measure showed no significant difference between Cerebrolysin and placebo. A subgroup finding was not the main planned result and does not prove a general recovery benefit.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

CASTA: adults with acute ischemic stroke studied for up to 90 days. The result applies to its planned primary measure and study population.

No FDA-approved U.S. Cerebrolysin product was identified in the reviewed approval database. An FDA substance record or orphan designation does not mean that FDA approved a product.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States regulatory status as reviewed August 30, 2026. Austrian authorization is a separate country status.

Cerebrolysin is a specific finished product and mixture. One 2015 sample contained 638 unique peptides. A 2024 study found different contents and activity in related products. A shared pig-brain source does not prove the same identity, contents, quality, or human evidence.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The named Austrian product and the exact product, process, composition, and quality record of any other preparation.

Small studies measured increases in reproductive hormones. Some also found short-term testosterone changes. These measurements do not prove a treatment benefit.

Evidence type

Human pharmacology
This answer uses a study of how the substance enters or changes the body in people. This alone does not show a health benefit.

Scope

Small, short studies in healthy men. The studies measured hormones, not fertility or treatment success.

Human studies mainly measured short-term hormone responses. FDA found too little evidence to judge whether Kisspeptin-10 treats secondary hypogonadism.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Treatment outcomes for infertility, low testosterone, or hypogonadism. Hypogonadism means that the sex glands do not make enough hormones.

No FDA-approved product was identified. An FDA identity record does not mean approval. FDA also lists Kisspeptin-10 among substances that may present significant safety risks in compounding.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States status as reviewed August 30, 2026.

For covered male athletes, the 2026 WADA list prohibits kisspeptin and its agonist analogues at all times.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The 2026 WADA rules for covered male athletes. Athletes must check the current rules that apply to them.

Yes. Randomized studies tested thymosin alpha-1 in people with specific illnesses. This only means human trials exist. It does not mean that they showed a benefit.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The exact study products and groups of people with each illness. A result from one illness does not transfer to another.

The corrected result was 23.4% with thymosin alpha-1 and 24.1% with placebo. The study found no clear difference in 28-day deaths.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The TESTS study randomized 1,106 adults with sepsis at 22 centers in China. The corrected analysis applies only to this study and outcome.

FDA says no approved U.S. drug contains thymosin alpha-1 free base or its acetate salt. Foreign product status does not create U.S. approval.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States regulatory status as reviewed August 30, 2026.

FDA's 2024 review describes Zadaxin as a finished medicine with narrow foreign approval. It is not the same as an ingredient name, a compounded product, or an online product.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The exact product, ingredient form, way it was made, and country status all matter.

Phase 3 trials and the product label support this outcome in the labeled population.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Adults with HIV and excess abdominal fat meeting the trial and label criteria.

The label specifically says it is not indicated for weight-loss management.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The current Egrifta SV and Egrifta WR labels.

The 2026 WADA Prohibited List names tesamorelin in the S2 peptide-hormone and growth-factor category, which is prohibited at all times for covered athletes.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Sport governed by the World Anti-Doping Code.

FDA records document the former Geref approvals. FDA later found that safety or effectiveness was not the reason for withdrawal.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Historical Geref products, not current compounded sermorelin.

A hormone response cannot show that people live longer or age more slowly.

Evidence type

Human pharmacology
This answer uses a study of how the substance enters or changes the body in people. This alone does not show a health benefit.

Scope

Hormone-response evidence cannot establish longer life or slower biological aging.

A former Geref approval does not make current compounded products FDA-approved. Current compounded products are not automatically the same as the former Geref products.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Current products marketed after Geref withdrawal.

FDA's identity record lists gonadorelin's 10-amino-acid sequence. The current cattle Factrel label says it has the same sequence as the body's GnRH. This identity fact does not make every product equivalent or approved.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The FDA-identified gonadorelin molecule only. It does not cover every product sold under the name.

FDA approved Factrel and Lutrepulse for human uses. Current Drugs@FDA records list both products as discontinued. That history does not mean that a current gonadorelin product is approved.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Former U.S. human products and current U.S. human drug records as reviewed August 30, 2026.

FDA lists current gonadorelin products for cattle. Their animal approvals do not approve them for people. One cattle product also uses the Factrel name, but it is not the former human Factrel product.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Current FDA-approved animal products for cattle, not human products.

Human studies used a pump to copy the body's normal signal pattern. They tested people with certain hormone disorders. They did not test gonadorelin during testosterone therapy.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

People using testosterone therapy; the reviewed pump studies did not test this claim.

For covered male athletes, the 2026 WADA Prohibited List names gonadorelin under testosterone-stimulating peptides.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Covered male athletes under the 2026 WADA rules; athlete-specific rules can differ.

FDA's identity record lists GHRP-6 as a hexapeptide, which means six amino acids, and gives its sequence. An identity record does not prove approval, quality, or equivalence between products.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The FDA-identified GHRP-6 molecule only. This identity fact does not cover every product sold under the name.

Small studies in healthy men measured short-term increases in growth hormone after GHRP-6. One study found that the response depended in large part on GHRH, another body signal. These are hormone measurements, not proof of treatment benefit.

Evidence type

Human pharmacology
This answer uses a study of how the substance enters or changes the body in people. This alone does not show a health benefit.

Scope

Small, short studies in healthy men; hormone response only, not muscle, fat loss, recovery, or other health outcomes.

A hormone response is not the same as a lasting health outcome. The reviewed human studies did not establish muscle gain or fat loss.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Muscle, fat-loss, and other lasting outcomes; the reviewed studies measured hormones or exposure only.

No FDA-approved human GHRP-6 product was identified in the checked U.S. databases as of August 30, 2026. FDA's substance identity record does not mean approval. This is a dated database finding, not a claim about every country or future record.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

U.S. human drug records checked on August 30, 2026.

FDA says it does not approve compounded drugs. Its current 503A list puts GHRP-6 in Category 3. This means the nomination did not have enough support. FDA also lists safety concerns for 503B compounding. A 2019 warning letter said GHRP-6 did not meet the 503A rules in that case.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

U.S. FDA records about compounded GHRP-6, checked August 30, 2026. This is not legal advice about one product.

The 2026 WADA Prohibited List names GHRP-6 under growth hormone-releasing factors. WADA prohibits it at all times, both in and out of competition.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Athletes subject to the 2026 WADA Prohibited List; rules can differ by sport and organization.

FDA describes TB-500 as a seven-amino-acid fragment of the much larger thymosin beta-4 molecule.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Chemical identity, not a claim about all possible biological activity.

The FDA evidence review did not identify adequate human outcome evidence for wound-healing use.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Clinical tendon, muscle, and wound-healing outcomes in people.

TB-500 is named on the current WADA Prohibited List.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Sport governed by the World Anti-Doping Code.

Yes, but the cited topical trial had 13 completers, found no significant objective improvement in erythema, wrinkles, or skin quality, and reported higher patient satisfaction. It does not establish broader outcomes or other routes.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

A specific topical copper-tripeptide formulation after CO2 laser resurfacing.

Route, formulation, exposure, product quality, and endpoint differ. Evidence cannot be transferred by ingredient name alone.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Topical study formulations versus compounded injectable products.

FDA identifies limited human data and potential immunogenicity related to aggregation and peptide impurities.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Compounded injectable GHK-Cu.

Preclinical metabolic findings are a real research signal, but they remain preclinical.

Evidence type

Preclinical evidence
This answer uses research in cells, animals, or other settings outside patient care. It does not show a benefit in people.

Scope

Laboratory and animal research, not patient outcomes.

FDA found no published human drug-product administration studies in its 2026 review.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Clinical weight outcomes from administered MOTS-c drug products.

FDA's substance registry explicitly states that UNII availability does not imply regulatory review or approval.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Substance identification versus drug-product approval.

FDA's review describes several human studies, primarily using oral or intravenous routes.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Historical study products and routes described in FDA's review.

Exposure and tolerability data do not establish a clinically meaningful weight-loss outcome.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Weight-loss efficacy, not merely participation in a study.

FDA identifies limited safety data, immunogenicity concerns, and missing information for proposed injectable use.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Compounded injectable AOD-9604.

A 2025 laboratory study reported telomere-length effects in cultured human cell lines.

Evidence type

Preclinical evidence
This answer uses research in cells, animals, or other settings outside patient care. It does not show a benefit in people.

Scope

Cultured cell lines, not health outcomes in treated people.

FDA did not identify clinical insomnia studies of the nominated epitalon substances by the proposed route.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Adults with insomnia assessed using clinical sleep outcomes.

The evidence does not provide reliable product-specific randomized lifespan outcomes for epitalon.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Human lifespan and healthspan outcomes attributable to epitalon.

Vyleesi is approved for acquired, generalized HSDD in certain premenopausal women after specified exclusions.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The population and limitations in the current Vyleesi label.

The label explicitly says the product is not for enhancing sexual performance and is not indicated for men or postmenopausal women.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Vyleesi's labeled indication and limitations.

The trial and approval record are product-specific and do not establish equivalence for compounded material.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Compounded or research-labeled bremelanotide products.

The label and randomized trials support this defined rare-disease outcome.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Adults with a history of phototoxic reactions from erythropoietic protoporphyria.

Its approval is for pain-free light exposure in adults with EPP, not cosmetic tanning.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The current FDA-approved indication.

Different molecules and products require their own identity, quality, safety, and outcome evidence.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Other melanocortin analogues and unapproved products.

The pivotal evidence and label support vertebral and nonvertebral fracture-risk reduction in studied high-risk populations.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Labeled osteoporosis populations at high fracture risk.

Fracture prevention and acute fracture healing are different endpoints, and trial results vary by fracture setting.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Acute fracture-healing outcomes across all fracture types.

The current label includes clinically important warnings, precautions, and population restrictions.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Approved teriparatide product use.

ACTIVE found fewer new vertebral and nonvertebral fractures versus placebo in postmenopausal women with osteoporosis.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Postmenopausal women with osteoporosis at fracture risk over 18 months.

Approved indications and trial populations define the evidence boundary.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Populations outside the current label and pivotal trial.

A prescription osteoporosis benefit-risk assessment does not establish safe enhancement in healthy people.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Healthy or athletic performance use.

Controlled trials and the Gattex label support this outcome in dependent short-bowel-syndrome populations.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Adults and labeled pediatric populations with short bowel syndrome dependent on parenteral support.

The approved indication and outcome are specific to short bowel syndrome with parenteral-support dependence.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The current Gattex indication.

The same biological activity underlies important warnings, including potential acceleration of neoplastic growth.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Approved Gattex use with required screening and monitoring.

A three-person 1996 phase 1 pilot measured increased pigmentation in two of three subjects using a defined subcutaneous dose of characterised drug. That is a real pharmacological signal and nothing more: it does not establish magnitude, durability, reproducibility at consumer doses, nasal-spray dosing, or safety.

Evidence type

Human pharmacology
This answer uses a study of how the substance enters or changes the body in people. This alone does not show a health benefit.

Scope

Pigmentation as a measured effect in a three-person 1996 pilot study using characterised drug; not consumer products, nasal sprays, or any claim about how much tan, for how long, or at what risk.

No trial of any kind has tested sunburn, ultraviolet damage, or skin cancer as an endpoint. The published record runs the other way: melanoma and dysplastic naevus case reports, a review counting four melanomas emerging from existing moles during or shortly after melanotan use, and an approved melanocortin-1 agonist whose label calls for twice-yearly full-body skin examination because it can darken pre-existing naevi.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

All protective or preventive framing, including the comparison with sunbeds.

Scenesse is a clinician-placed controlled-release implant of afamelanotide, a different molecule that binds predominantly to the melanocortin-1 receptor, approved for photosensitivity in erythropoietic protoporphyria. Vyleesi is bremelanotide, approved for a defined sexual-desire disorder in certain premenopausal women. Melanotan II is neither molecule and has no approval, no label, no established dose, and no verified vial content.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Both versions of the confusion: melanotan marketed as equivalent to the approved Scenesse implant, and melanotan II marketed as a cheaper route to the approved bremelanotide effect.

Research-use-only wording is a marketing label, not a legal status for human use. Selling and supplying melanotan injections is illegal in the UK. Australia's regulator treats melanotan II as a prescription-only medicine that is unapproved, and issued one supplier 27 infringement notices totalling AU$101,412. That same research-chemical channel is the one whose products were found to contain roughly 43 to 88 per cent of the labelled amount plus unidentified impurities.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The legality of sale and supply, which is where enforcement in these jurisdictions is directed; it says nothing about what happens to an individual purchaser.

Nausea is the dominant effect in the trial record, severe in 12.9 per cent of subjects at the higher dose in the 2000 study. But the published case literature also contains rhabdomyolysis and renal impairment requiring intensive care, renal infarction affecting roughly half a kidney, and acute ischaemic priapism that failed drug and irrigation treatment and required surgical decompression, a time-critical emergency carrying permanent erectile-dysfunction risk. These are case reports: they prove occurrence, not frequency. The honest statement is that the frequency of serious harm is unknown because no surveillance system exists, not that serious harm is rare.

Evidence type

Observational human evidence
This answer uses observations or reports from people. They can show what happened, but may not prove the substance caused it.

Scope

The completeness of the adverse-effect picture. Case reports establish that these events happened after use with temporal association; they cannot establish incidence or causation.

FDA identifies Semax as a heptapeptide with the sequence Met-Glu-His-Phe-Pro-Gly-Pro. This identifies the free-base peptide and does not make other chemical forms or products interchangeable.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Semax free base as identified in FDA's substance and briefing records; the acetate form is a separate chemical form.

FDA found no supporting literature for ADHD. A 24-person study measured resting brain-scan connections, not focus, memory, attention, or daily function.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Focus, memory, and ADHD claims made for Semax; not a finding about the laboratory or animal literature.

FDA staff found insufficient evidence of effectiveness for cerebral ischemia, migraine, or trigeminal neuralgia. The two stroke studies listed here have important design and comparison limits.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

The uses reviewed by FDA in 2026; this does not assess every possible research question.

FDA says Semax free base and Semax acetate are not components of an FDA-approved drug. A drug registered in Russia does not create U.S. approval.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States approval status as reviewed August 30, 2026.

RAPS reported an 8-5 advisory-committee vote in favor of adding Semax to the 503A list. FDA says advisory recommendations are non-binding, and the briefing says FDA had not made its final determination. No final FDA rule or listing was identified in this review.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The July 2026 advisory vote and U.S. 503A status as reviewed August 30, 2026; a recommendation is not a final FDA decision or drug approval.

FDA identifies Semax free base and Semax acetate as distinct active ingredients. PubChem identifies N-acetyl Semax amidate as a chemically modified substance. A shared name does not establish the same structure, quality, safety, or evidence.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Chemical-form and product-identity comparisons; this is not a use or administration recommendation.

Yes. FDA lists Selank, Selanc, and TP-7 as names for one peptide with the sequence TKPRPGP. This record names the substance. It does not show that a related chemical form or sold product is the same.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The Selank peptide in FDA's chemical record. Selank diacetate has a separate related record.

Yes. One randomized report compared Selank with medazepam in 62 people. Another randomized report included 70 people. Forty received Selank with phenazepam, and 30 received phenazepam alone. These small studies do not prove a broad benefit.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

Small studies in people with specific anxiety-related conditions. The reports do not establish a result for every anxiety condition or population.

The studies were small and compared Selank with another medicine. The reports did not clearly say whether people and researchers knew the assigned treatment. No large, repeated result against a placebo was found.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

A reliable treatment conclusion for anxiety disorders across people, settings, and products.

A 52-person study measured links between brain areas. It did not test focus, memory, or daily function. An earlier report mentioned a possible effect on thinking, but its study summary gave no clear result for these outcomes.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Focus, memory, and daily-function outcomes in people who received a verified Selank study product.

No FDA-approved U.S. Selank product was found in the records checked. FDA's chemical record names the substance. It does not approve a drug. The request to add Selank acetate to a compounding list was withdrawn. That request was not approval.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States drug-approval and compounding records checked on August 30, 2026.

FDA has separate records for the main peptide and Selank diacetate, a related chemical form. A product name does not prove what it contains, its quality, or whether it matches the product used in a study.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The peptide, its related chemical form, and each finished or compounded product must be checked separately.

The human studies were small and cannot show uncommon or long-term harms. FDA says important human safety information is missing for Selank acetate. For some ways of using it, FDA also warns of possible immune reactions from peptide clumps or related impurities.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Long-term safety, uncommon harms, and the safety of each way it is used, chemical form, and finished product.

Yes. FDA's substance and briefing records use emideltide for DSIP and identify a nine-amino-acid sequence. This name match does not make free base, acetate, or online products equivalent.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

FDA substance identity records for DSIP and emideltide; this does not establish the identity or quality of an online product.

Small older human studies had mixed results. Some used controls, while others had important design limits. Together, they do not prove that DSIP improves sleep or treats insomnia.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Small human sleep studies using different designs, products, routes, and follow-up periods; the results do not establish a general treatment benefit.

Small older studies examined withdrawal symptoms, but they did not establish that DSIP treats opioid or alcohol withdrawal. The findings do not support a general treatment claim.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

The small human withdrawal studies reviewed; this does not establish a treatment benefit for withdrawal or any other condition.

FDA's briefing did not identify an FDA-approved U.S. drug containing emideltide. The current U.S. 503A list also does not list DSIP or emideltide. A substance record or a foreign or online product is not U.S. drug approval.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States approval and 503A status as reviewed August 30, 2026.

The July 2026 committee vote was advisory. It did not itself change the 503A list or approve a drug. The current U.S. list does not show DSIP or emideltide, and no final FDA approval was identified in this review.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The July 2026 advisory vote and United States 503A status as reviewed August 30, 2026; an advisory recommendation is not a final FDA decision or drug approval.

FDA separates emideltide free base and emideltide acetate. An online product may have a different form, contents, or quality. The names alone do not show that these products are interchangeable.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

Chemical-form and product-identity comparisons; this is not a use or administration recommendation.

FDA's detailed chemical record lists ropocamptide as a peptide with 37 amino acids. This record does not show product quality or human benefit.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

FDA identity records for LL-37 and ropocamptide; this does not establish the identity or quality of an online product.

The first 34-person leg-ulcer study reported possible benefit. A later study assigned 149 people to LL-37 or placebo. Of those people, 148 received a study treatment. It found no clear benefit for the full group. A 25-person diabetic-foot-ulcer study found a limited sign of new tissue growth, but no clear changes in other measures. These results do not prove general wound healing.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The reviewed venous-ulcer studies and small diabetic-foot-ulcer study; results apply only to their defined products, groups, wound types, and follow-up periods.

The 238-person study used an engineered bacterium that made a lab-produced form of LL-37. Patients and researchers knew which treatment was given. The study took place at one medical center. It did not test a standard LL-37 vial, spray, or plain peptide product.

Evidence type

Randomized human outcomes
This answer uses a study that assigned people to groups by chance and measured a health outcome.

Scope

The engineered bacterium used in the study and the one-center setting; this does not establish results for other LL-37 materials.

No FDA-approved U.S. LL-37 drug was found when Drugs@FDA was checked for LL-37 and ropocamptide on August 30, 2026. An FDA chemical record identifies a substance. It does not mean that FDA approved a drug.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States approval status as reviewed August 30, 2026.

The person or group who asked FDA to consider LL-37 for its pharmacy-compounding list withdrew the request. That request was called a 503A nomination. Its withdrawal is not a ban. The current federal rule does not list LL-37. FDA plans an advisory-committee discussion before the end of February 2027. That discussion is not a final decision or drug approval.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The U.S. pharmacy-compounding status as reviewed August 30, 2026; an advisory discussion is not a final FDA action.

FDA has separate records for ropocamptide (LL-37) and LL-37 amide. An online product name does not prove the same chemical form, amino-acid order, purity, or quality.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

FDA identity records and online product names; this is not advice on how to use a product.

Yes. FDA lists P21 and P021 as names for the P-21 chemical record. This name match does not prove that a sold product has the same contents or quality.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

The FDA chemical identity record; this does not establish drug approval, product quality, or human benefit.

Yes. Studies reported learning or memory findings in normal mice and in mouse models of Alzheimer-like disease. Results in mice do not prove a benefit in people.

Evidence type

Preclinical evidence
This answer uses research in cells, animals, or other settings outside patient care. It does not show a benefit in people.

Scope

Normal adult mice and genetically changed mouse models; not people with memory problems or Alzheimer’s disease.

The reviewed studies used mice, rats, or cells. The P021 registry search found no study in people. Animal or cell findings cannot show that P21 treats people.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

Memory or Alzheimer’s disease outcomes in people who received a verified P21 study product.

FDA says a Unique Ingredient Identifier, or UNII, helps identify a substance. It does not mean that FDA reviewed or approved a drug. No FDA-approved P21 product was found under the reviewed names.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

United States drug-approval status as checked for P21, P021, and P-21 on August 30, 2026.

No. P21 peptide is a small compound made in a lab. CDKN1A is a human gene. It makes a protein also called p21. The shared short name does not make them the same.

Evidence type

Regulatory or product record
This answer uses an official regulator record or a specific product label.

Scope

P21 peptide identity compared with the human CDKN1A gene and p21 protein.

The P021 registry search found no study in people. Animal studies cannot set a safe amount, rule out uncommon harm, or show long-term safety for people.

Evidence type

No reliable human outcome evidence
No reliable study in people shows the health outcome in this statement.

Scope

People exposed to a verified P21 study product, with enough follow-up to assess harms.